TABLE 40Results reported for non-responders (maintenance trials)

StudyWere non-responders randomised to maintenance treatment?Were results reported for both responders and non-responders separately (RCT only)?
CLASSIC II66

(adalimumab)
No

Only those patients (from CLASSIC I63) in remission at week 0 and 4 eligible for randomisation; those not in remission at week 0 or no longer in remission at week 4 entered an open-label cohort
No

Results reported for patients not eligible for randomisation who entered open-label cohort
ACCENT I23

(infliximab)
Yes

Responders and non-responders randomised
No

Results for ALL patients (responders + non-responders) reported in Rutgeerts et al.;2 results for responders only reported in Hanauer et al.3

Industry submission: subgroup analysis of mucosal healing and CDEIS scores in responders and non-responders together; hospitalisation and surgery reported for responders and non-responders together
Rutgeerts et al., 199958

(infliximab)
No

Responders from Targan et al.57 RCT eligible

Initial non-responders in Targan et al.57 given an additional 8 weeks of open-label treatment during which they could respond and still be eligible for maintenance treatment

Unclear if any responders drawn from placebo group of RCT
No

No non-responders included in RCT

Proportion of non-responders at week 4 (Targan et al.57 RCT) subsequently responding during open-label treatment unclear
ACCENT II65

(infliximab, fistulising)
Yes

Non-responders randomised for secondary analysis
Yes

Results reported for response
REACH45

(infliximab, paediatric)
No

Only responders randomised (no placebo control)
No

No non-responders included in RCT (no placebo control)
CHARM67

(adalimumab)
Yes

Non-responders randomised for secondary analysis (randomisation stratified by responder status)
No

Stated that secondary efficacy analyses were conducted for total population, but results presented only for fistula closure, which relates to a subgroup of patients (15% of patients have fistula)

Industry submission: present results (remission, CDAI decrease > 70, CDAI decrease > 100, IBDQ score) for responders and for patients with CDAI > 300

The trial report submitted to NICE contained information on non-responders

From: 3, Assessment of clinical effectiveness

Cover of A Systematic Review and Economic Evaluation of the Use of Tumour Necrosis Factor-Alpha (TNF-α) Inhibitors, Adalimumab and Infliximab, for Crohn's Disease
A Systematic Review and Economic Evaluation of the Use of Tumour Necrosis Factor-Alpha (TNF-α) Inhibitors, Adalimumab and Infliximab, for Crohn's Disease.
Health Technology Assessment, No. 15.6.
Dretzke J, Edlin R, Round J, et al.
Southampton (UK): NIHR Journals Library; 2011 Feb.
© 2011, Crown Copyright.

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